Morbid ObesityNCT02325141
Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection
A study testing laparoscopic sleeve gastrectomy in people with Morbid Obesity, run by Mansoura University.
Trial summary
Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- laparoscopic sleeve gastrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index >40 or >35 with hypertension or DM
Who cannot join
- Previous bariatric surgery
About this study
Official title: Laparoscopic Sleeve Gasterectomy With or Without Pyloric Sphincter Botulinum Neurotoxin Injection: a Comparative Study
Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.
Read the detailed description
Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.
- Conditions
- Morbid Obesity
- Being tested
- laparoscopic sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyProcedure or surgery
creation of a gastric tube of 100cc using a stapler.
| Study group | Role | What they receive |
|---|---|---|
| LSG | Active comparator | patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter Receives: Procedure: laparoscopic sleeve gastrectomy |
| BTX-LSG | Active comparator | patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter Receives: Procedure: laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number pf patients developing postoperative gastric leakage
Measured: 0ne year
Secondary outcomes (1)
percent of patients with excess weight loss
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Youssef Mohamed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325141
- Sponsor's protocol ID
- MFM201040
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sleeve Gasterectomy With or Without Pyloric Sphincter Botulinum Neurotoxin Injection: a Comparative Study
- ClinicalTrials.gov ID
- NCT02325141
- Acronym / sponsor ID
- MFM201040
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.
Detailed description
Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSG | Active comparator | Procedure: laparoscopic sleeve gastrectomypatients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter |
| BTX-LSG | Active comparator | Procedure: laparoscopic sleeve gastrectomypatients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index >40 or >35 with hypertension or DM
Key exclusion criteria (1 listed)
- Previous bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic sleeve gastrectomycreation of a gastric tube of 100cc using a stapler. | Procedure or surgery | BTX-LSG, LSG |
Primary outcome
number pf patients developing postoperative gastric leakage
Time frame: 0ne year
1 secondary outcome
percent of patients with excess weight loss
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sleeve gastrectomy in people with Morbid Obesity, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number pf patients developing postoperative gastric leakage (time frame: 0ne year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.